Wed.Mar 13, 2024

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Automation, risk management, and the manufacture of medical devices

Pharmaceutical Technology

As the demand for medical devices continues to rise, manufacturers are increasingly turning to automation during the assembly process to get their products to market faster. But how can the risks involved be mitigated?

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Many Dementia Cases Could Actually Be a Hidden Form of Liver Disease

AuroBlog - Aurous Healthcare Clinical Trials blog

A recent study of US veterans found that 10% of those diagnosed with dementia actually had a liver condition called hepatic encephalopathy (HE) – a treatable condition. The liver can be damaged by several things, including alcohol, fatty deposits and hepatitis viruses.

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Bright Green invests $250m to expand facility in New Mexico, US

Pharmaceutical Technology

Bright Green has announced plans to expand its controlled substances drug production facility in New Mexico, US with an investment of $250m.

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NABL Kolkata spearheads cutting-edge awareness programme on calibration of medical devices

AuroBlog - Aurous Healthcare Clinical Trials blog

In order to set in pioneering progress in Eastern India’s laboratory standards, the National Accreditation Board for Testing and Calibration Laboratories (NABL) Kolkata office has orchestrated a ground-breaking virtual awareness program, revolutionizing perspectives on calibration within the Eastern India region’s laboratories.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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FDA to focus on ‘early deaths’ in meeting on broader CAR-T use in myeloma

Bio Pharma Dive

Briefing documents posted ahead of Friday’s advisory panel zeroed in on increased rates of early death in tests of cell therapies from Bristol Myers Squibb and Johnson & Johnson.

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Risk adjusted net present value: What is the current valuation of AstraZeneca’s AZD-3427?

Pharmaceutical Technology

AZD-3427 is commercialized by AstraZeneca, with a leading Phase II program in Pulmonary Hypertension.

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March 13, 2024: In This Friday’s PCT Grand Rounds, a Pragmatic Trial of Antibiotic Choice on Renal Outcomes

Rethinking Clinical Trials

Dr. Edward Qian In this Friday's PCT Grand Rounds, Edward Qian of Vanderbilt University will present "The Effect of Antibiotic Choice on Renal Outcomes: The ACORN Trial." The Grand Rounds session will be held on Friday, March 15, 2024, at 1:00 pm eastern. The ACORN trial compared the effects of cefepime vs piperacillin-tazobactam on the incidence of acute kidney injury among acutely ill adults.

Trials 184
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Risk adjusted net present value: What is the current valuation of Novo Nordisk’s Belcesiran?

Pharmaceutical Technology

Belcesiran is an antisense rnai oligonucleotide commercialized by Novo Nordisk, with a leading Phase II program in Alpha-1 Antitrypsin Deficiency (A1AD).

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IFM, an unorthodox biotech startup, scores third buyout with Novartis deal

Bio Pharma Dive

With a decision by the Swiss pharma to acquire another one of its subsidiaries, IFM Therapeutics has now sold three spin-offs for $700 million upfront and the potential for billions more in future payments.

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US study reveals age-related skin changes could contribute to melanoma metastases

Pharma Times

Around 200,000 people in the US are expected to be diagnosed with the skin cancer this year

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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FDA Approves Madrigal’s Rezdiffra as First MASH Therapy

BioSpace

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.

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AbbVie’s Produodopa approved by SMC to treat Parkinson’s disease patients in Scotland

Pharma Times

The progressive neurological disorder affects approximately 12,400 people in Scotland

Medicine 142
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Merck to start trials investigating single dosing regimen of HPV vaccine

Pharmaceutical Technology

The two trials will evaluate alternative dosing regimens for Gardasil 9 vaccine compared to the currently approved three-dose regimen.

Vaccine 130
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Transitioning PROs from paper to digital: Maintaining data integrity and patient experience

pharmaphorum

Transitioning patient-reported outcomes (PROs) from paper to digital (ePRO) is crucial for maintaining data integrity and improving the patient experience. Learn how to seamlessly make this transition and optimise your data collection process.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Galderma sets price range for supersized $2.6bn IPO in Europe

Pharmaceutical Technology

The dermatology-centric pharma company is likely set for one of the biggest public listings in Europe since 2022.

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Digitalising supply chains may be the zeitgeist, but let’s not forget about the power of human partnerships

pharmaphorum

Digitalising supply chains may be the zeitgeist, but let’s not forget about the power of human partnerships Mike.

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Quality versus quantity in T-cell production: Why it doesn’t have to be a trade-off

Pharmaceutical Technology

In T-cell manufacturing, the historical issue of maintaining the quality of materials when scaling up production is changing.

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Lilly adds Amazon Pharmacy to LillyDirect DTC channel

pharmaphorum

Amazon Pharmacy will provide dispensing for Eli Lilly’s recently launched direct-to-consumer LillyDirect channel, covering obesity, diabetes, and migraine drugs.

Pharmacy 116
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Lamassu Bio secures US NIH grant for sarcoma treatment

Pharmaceutical Technology

Lamassu Bio has received a $2.05m grant from the US National Institutes of Health (NIH) and National Cancer Institute (NCI) for the development of SA53, a new therapeutic for p53 wild-type sarcomas.

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BaseCamp unveils improved protein structure prediction model

pharmaphorum

Basecamp Research launches BaseFold, a deep learning model that it says surpasses benchmark tool AlphaFold2 and should accelerate AI-based drug discovery

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Allumiqs and Prolytix collaborate for drug discovery

Pharmaceutical Technology

Allumiqs has entered into a long-term strategic collaboration with Prolytix to expedite the discovery and development of new drugs.

Drugs 130
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World Glaucoma Week 2024: New Advances in Glaucoma Care

XTalks

World Glaucoma Week is an initiative that began with the collaborative efforts of the World Glaucoma Association (WGA) and the World Glaucoma Patient Association (WGPA). It evolved from World Glaucoma Day, which was first commemorated on March 6, 2008. The theme for World Glaucoma Week 2024 is “Uniting for a Glaucoma-Free World.” This year’s week-long campaign is a platform for eye care professionals, health organizations and the medical device and healthcare industry to share the latest knowled

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pearl Bio and Merck partner for discovery of cancer therapies

Pharmaceutical Technology

Pearl Bio has signed an agreement with Merck for the discovery of biologics that incorporate non-standard amino acids to treat cancer.

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From a childhood fascination to a pull towards translational medicine, who is this week's Woman in Science?

BioPharma Reporter

Kate Broderick takes us on her intriguing journey - from being drawn to how science was applied within a medical setting, to the enormous challenge of working around the clock when the pandemic began.

Medicine 110
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Biotech trade group pledges support for BIOSECURE Act, plans to boot member WuXi AppTec

Fierce Pharma

As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C. | As CDMO giants Wuxi AppTec and WuXi Biologics come under mounting scrutiny for their alleged ties to Chinese government officials, they are losing a key ally in Washington, D.C.

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Recently Laid Off? Contract Work Could Be an Attractive Option

BioSpace

Staffing agencies say contract work is a great way to break into an industry and avoid a resume gap.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Building Cancer Awareness and Empowering Métis Youth: Featuring Jordyn Playne, President, Métis Nation of Ontario Youth Council – Xtalks Life Science Podcast Ep. 150

XTalks

In this episode, Ayesha spoke with Jordyn Playne, President of the Métis Nation of Ontario (MNO) Youth Council , a group of youth representatives from across Ontario who advocate on behalf of the concerns and interests of Métis youth at the provincial level. Jordyn is also a Clinical Consultant and Trainer at Waypoint Centre for Mental Health Care, as well as an advocate for cancer prevention.

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SXSW 2024 Insights: Why the Greatest Risk a Brand Can Take Is Being Ordinary, Part 1

Intouch Solutions

Our team is on the ground at SXSW 2024, and as we navigate through the bustling streets of downtown Austin, Texas — where the magic of immersive brand experiences dress the streets — we can’t help but feel the pulse of innovation surrounding us. In this blog, Hattie Stearns, Senior Director, Experience Design & Innovation, delves into several key trends and insights from Day 1 of the conference, including the importance of building authentic immersive experiences that enable human connection

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A Changing of the Guard: Robert P. Mauch to Become CEO in October 2024

Pharmaceutical Commerce

Steven H. Collis, who currently holds the position, will transition to executive chair of the board.

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FDA reviewer pokes holes in Geron’s MDS drug data

pharmaphorum

FDA reviewers seem unconvinced by Geron's data on myelodysplastic syndrome therapy imetelstat ahead of FDA adcomm meeting.

Drugs 105
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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud